Mundipharma Research Limited (Mundipharma) has announced a major milestone in the development programme of flutiform® (fluticasone propionate/formoterol fumarate) for the treatment of Chronic Obstructive Pulmonary Disease (COPD) with the commencement of a key clinical trial. COPD is a life-threatening lung disease that interferes with normal breathing, estimated to affect at least 64 million people worldwide.(1)
The first patient in the trial is expected to start treatment with flutiform this month.
The Effect (Efficacy of Fluticasone propionate/FormotErol in COPD Treatment) study has been designed to investigate the superiority of flutiform 250/10μg (2 puffs bid) and flutiform 125/5μg (2 puffs bid) compared with formoterol 12μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations over the 52-week treatment period.
“flutiform has already been approved as a maintenance therapy for asthma in adults and adolescents. We’re excited with the progress that we’ve made to date with this combination and we believe that it also has the potential to be an important new treatment option for patients suffering from COPD,” commented Prof Dr Karen Reimer, Managing Director, Mundipharma Research Limited.
This is the first large scale COPD study to evaluate two different doses of an ICS (Inhaled Corticosteroid)/LABA (Long-Acting Beta Agonist) combination, where the dose of both components is adjusted. The study will include recently developed COPD assessment tools which may further our understanding of this disease and will also evaluate serum biomarkers relevant to this multisystem disease. The study will provide useful new insights for clinicians into the management and assessment of COPD.
“The Mundipharma network of independent associated companies is committed to expanding our product offering in respiratory diseases including COPD, a chronic and debilitating disease which is predicted to become the third leading cause of death worldwide by 2030” added Georg Toufar, Chief Marketing Officer, Mundipharma International Ltd.
Study design
The primary objective of the Effect study is to show superiority in the efficacy of fluticasone propionate/formoterol fumarate 250/10 μg (2 puffs bid) compared with formoterol 12μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations during the 52-week treatment period.
The study is a Phase III multi-centre, randomised, double-blind and double dummy, placebo and active-controlled, parallel-group study comparing fluticasone propionate/formoterol fumarate 250/10μg (2 puffs bid) and fluticasone propionate/formoterol fumarate 125/5μg (2 puffs bid) versus formoterol fumarate dihydrate 12μg (1 puff bid) in subjects with COPD.
Approximately 1,530 patients will be randomised in order to achieve 510 patients in each treatment group stratified for FEV1 % predicted category at baseline (FEV1 < 30% predicted, or 30-50 % predicted) and number of exacerbations in the previous year (≥ 2 or < 2).
Patients from approximately 15-20 countries will participate in the trial, including Bulgaria, Czech Republic, Germany, Hungary, Latvia, Macedonia, Poland, Romania, the Russian Federation, Slovakia, South Africa, South Korea, Spain, Ukraine and the UK.
flutiform is not currently licensed for the treatment of COPD
Reference:
- World Health Organisation. http://www.who.int/respiratory/copd/en/ (Accessed Sept 2013). Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. (Accessed: Sept 2013).
